Postoperative Neurocognitive Dysfunction After Major Abdominal Surgery: A Prospective Observational Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Elective Major Abdominal Surgery
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Incidence of delirium during first 7 days after surgery
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Predisposing and precipitating factors for perioperative delirium for the elderly remain elusive. This research will be conducted to determine risk factors of postoperative delirium.
Detailed Description
This study intends to include 500 participants over 65 years old undergoing elective abdominal major surgery. The primary outcome is incidence of delirium at 7 days postoperatively, and the secondary outcomes include preoperative sleep disorders(Athens In-somnia Scale, AIS), postoperative cognitive impairment (Abbreviated Mental Test Score, AMTS), postoperative pain (NRS pain score), incidence of significant postoperative complications, length of hospital stay, and serum biomarkers levels.
Investigators
Xiangcai Ruan, MD, PhD
Professor
Sixth Affiliated Hospital, Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); ,
- •American society of Aneshesiologists（ASA）physical status I-III;
Exclusion Criteria
- •Mini-Mental State Examination (MMES) score \< 15;
- •Renal failure (requiring dialysis) or liver failure (Child-Pugh score \> 5);
- •Severe impairment due to structural or hypoxic brain injury, more than 2 days in ICU one month before surgery;
- •Underwent major heart, lung or abdominal surgery within 1 year;
- •Positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or symptomatic (e.g. fever, cough, loss of taste/smell);
- •The cognitive assessment cannot be completed because the subject is blind, deaf, or unable to communicate in the local language;
- •Long-term follow-up unavailable (homelessness, active psychosis or substance abuse).
Outcomes
Primary Outcomes
Incidence of delirium during first 7 days after surgery
Time Frame: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.
The result of 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) is positive.
Secondary Outcomes
- Postoperative pain(Consecutive 7 days after the surgery or hospital discharge, whichever comes first.)
- Length of hospital stay(Up to 24 weeks after surgery)
- All-cause mortality at 30 days after surgery(Up to day 30 after surgery)
- Preoperative cognitive function(Day 1 before surgery)
- Preoperative Sleep quality(Day 1 before surgery, Day 3 after surgery)
- Health status and quality of life(Day 1 before surgery, day 30 after surgery)
- Serum biomakers levels(Within 15 minutes after induction of anesthesia, day 3 after surgery)
- Postoperative adverse complications(Up to day 30 after surgery)
- Age-adjusted Charlson Comorbidity Index(Day 1 before surgery)
- Preoperative anxiety(Day 1 before surgery, day 3 after surgery)
- Postoperative cognitive dysfunction(Day 1 before surgery, day 30 after surgery, day 90 after surgery)